BUPRENORPHINE\BUPRENORPHINE: 47 Adverse Event Reports & Safety Profile
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47
Total FAERS Reports
16 (34.0%)
Deaths Reported
9
Hospitalizations
47
As Primary/Secondary Suspect
3
Life-Threatening
3
Disabilities
Active Ingredient: BUPRENORPHINE\BUPRENORPHINE HYDROCHLORIDE ·
First Report: 20201101 · Latest Report: 20240623
What Are the Most Common BUPRENORPHINE\BUPRENORPHINE Side Effects?
#1 Most Reported
Vomiting
12 reports (25.5%)
#2 Most Reported
Abdominal pain upper
10 reports (21.3%)
#3 Most Reported
Pain
9 reports (19.1%)
All BUPRENORPHINE\BUPRENORPHINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Vomiting | 12 | 25.5% | 6 | 2 |
| Abdominal pain upper | 10 | 21.3% | 6 | 1 |
| Pain | 9 | 19.2% | 5 | 2 |
| Blepharospasm | 8 | 17.0% | 4 | 1 |
| Drug intolerance | 8 | 17.0% | 4 | 1 |
| Epilepsy | 8 | 17.0% | 4 | 1 |
| Gastrooesophageal reflux disease | 8 | 17.0% | 4 | 1 |
| Hypoaesthesia | 8 | 17.0% | 4 | 1 |
| Memory impairment | 8 | 17.0% | 4 | 1 |
| Paraesthesia | 8 | 17.0% | 4 | 1 |
| Taste disorder | 8 | 17.0% | 4 | 1 |
| Arthralgia | 7 | 14.9% | 7 | 1 |
| Asthenia | 7 | 14.9% | 6 | 1 |
| Central sleep apnoea syndrome | 7 | 14.9% | 0 | 0 |
| Diarrhoea | 7 | 14.9% | 7 | 1 |
| Dizziness | 7 | 14.9% | 7 | 1 |
| Drug ineffective | 7 | 14.9% | 3 | 0 |
| Maternal exposure during pregnancy | 7 | 14.9% | 4 | 3 |
| Nausea | 7 | 14.9% | 6 | 1 |
| Product use in unapproved indication | 7 | 14.9% | 4 | 1 |
Who Reports BUPRENORPHINE\BUPRENORPHINE Side Effects? Age & Gender Data
Gender: 59.6% female, 40.4% male. Average age: 45.3 years. Most reports from: US. View detailed demographics →
Is BUPRENORPHINE\BUPRENORPHINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2020 | 1 | 0 | 0 |
| 2022 | 3 | 3 | 0 |
| 2023 | 4 | 0 | 3 |
| 2024 | 6 | 0 | 1 |
What Is BUPRENORPHINE\BUPRENORPHINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 27 |
| Drug dependence | 5 |
Official FDA Label for BUPRENORPHINE\BUPRENORPHINE
Official prescribing information from the FDA-approved drug label.